# FDA 483 - Chesapeake Medical Products, Inc. - July 12, 2024

Source: https://www.keypedia.com/records/483/chesapeake-medical-products-inc/bd0e0040-68f9-463a-ba8c-6d6a301476de

> FDA 483 for Chesapeake Medical Products, Inc. on July 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chesapeake Medical Products, Inc.
- Inspection Date: 2024-07-12
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Chesapeake Medical Products, Inc. in Baltimore, MD, a medical device manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The observations highlight a systemic failure to adhere to established procedures for nonconforming product control, complaint handling, vendor management, management review, and internal quality audits. These issues indicate a lack of effective quality system implementation and oversight.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/chesapeake-medical-products-inc/130a0048-28c9-4f0e-8067-21b904e0f0c5

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64